Cleared Traditional

Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

K230887 · Sysmex America, Inc. · Hematology
Dec 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K230887 is an FDA 510(k) clearance for the Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 21, 2023, 265 days after receiving the submission on March 31, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K230887 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date December 21, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220